What is CT1190B studying for B-cell Non-Hodgkin Lymphoma?

CT1190B is being studied as a new CAR-T cell therapy for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. Researchers aim to evaluate the safety, effectiveness, and cell behavior of this treatment to better understand its potential in managing this lymphoma. The study is led by Kai Hu and involves careful monitoring of participants over time.

Who may be eligible for this B-cell Non-Hodgkin Lymphoma clinical trial?

Adults aged 18 to 75 years with confirmed B-cell Non-Hodgkin Lymphoma who have received at least two prior systemic treatments may be eligible. Participants must have measurable disease, an ECOG score of 0 or 1, and be able to follow the study schedule including long-term follow-up. Please review eligibility criteria for more details.

Is there any cost to participate in this B-cell Non-Hodgkin Lymphoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 1

Age: 18Years - 75Years

All Genders

ID06822868

Study of CT1190B CAR-T Cell Therapy in Adults 18 to 75 Years with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Evaluating Safety, Treatment Effectiveness, and Cellular Behavior

Led by Kai Hu · Updated on 2025-02-12

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and cellular metabolism of CT1190B CAR-T cell therapy in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma B-NHL. This is an early-phase, single-arm, open-label clinical study enrolling between 6 and 24 participants to explore how these specialized immune cells behave and impact the disease. Participants will receive an infusion of CT1190B CAR-T cells as the experimental treatment. The study focuses on assessing the dose range and safety within 28 days after infusion. It includes monitoring overall response and remission rates at 4 weeks, 8 weeks, 12 weeks, and then at 6, 9, and 12 months post-infusion. During the study, participants will undergo regular evaluations including safety assessments for adverse events up to 12 months after infusion. Researchers will monitor response times, duration of remission, progression-free survival, and overall survival over one year. Long-term follow-up is planned for up to 15 years to gather extended safety and efficacy data. Participants will be closely observed through scheduled visits and tests throughout the study period.

CONDITIONS

Brief Title

A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Participants must voluntarily sign the informed consent form and agree to adhere to study visits and protocol requirements, including long-term follow-up for up to 15 years
Age between 18 and 75 years
Histologically or cytologically confirmed B-cell Non-Hodgkin Lymphoma
Previously received at least two lines of systemic therapy
Intolerance to last treatment, or disease progression on or after last treatment requiring therapy
Presence of measurable target lesions
Expected survival greater than 12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Female participants of childbearing potential must have a negative pregnancy test before treatment and agree to use effective contraception for 1 year after treatment; male participants must also use effective contraception if sexually active with female partners of childbearing potential
Participants must not donate eggs or sperm for 1 year after receiving study treatment infusion

You will not qualify if you...

Pregnant or breastfeeding women
Infection with HIV, syphilis, active hepatitis B or C virus
Current uncontrolled active infections including active tuberculosis
Toxicities from previous treatments not resolved to mild or better (grade 1 or less), except alopecia or other tolerable events
Treatment for the disease within 14 days before informed consent, including cytotoxic therapy, monoclonal antibodies, targeted therapy, radiotherapy, epigenetic therapy, investigational agents, or invasive devices
Use of systemic glucocorticoids equivalent to more than 15 mg/day prednisone within 7 days prior to consent, except topical glucocorticoids
Vaccination with live, inactivated, or RNA vaccines within 4 weeks prior to consent
Allergy or intolerance to preconditioning drugs, tocilizumab, or history of severe allergy such as anaphylaxis
Any heart disease within 6 months prior to screening
Oxygen saturation below 92%
Presence of a second primary cancer requiring treatment or not in remission within 2 years
Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment, excluding minor local anesthesia procedures
Inability or unwillingness to comply with study protocol or judged unsuitable by investigator

Research Team

Kai Hu MD

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